NCT02466412

Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 23 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	CHTP 1.1 M	Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
OTHER	mCC	Single use of subject's own menthol conventional cigarette (mCC)

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-11-01
• First posted: 2015-06-09
• Last updated: 2020-05-13
• Results posted: 2017-04-11

Locations

1 site across 1 country: Japan